Anal 2 Electrode Stimulation/EMG Probe - W/Stop

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K990456 ↗

FDA Product Code

KPI

Device Class

Class II

Regulation

21 CFR Part 876.5320

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• Heelbo Quilted Torso Restraint

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  FDA 510(k) K963108 Active Cleared 9 Oct 1996

• Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe

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• Incare Pinsite Dressing

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  FDA 510(k) K905206 Active Cleared 12 Apr 1991

• Checkmate Ankle Restraint System

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• Microgyn II Elec Stim Device Treat of Urin Inconti

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See all devices from Hollister, Inc. →

• What is the Anal 2 Electrode Stimulation/EMG Probe - W/Stop used for?

  This device is used for pelvic floor therapy, providing electromyographic (EMG) sensing or electrical stimulation of pelvic musculature to assist in muscle rehabilitation and neuromuscular control restoration. It is inserted anally for this purpose.

• Is the Anal 2 Electrode Stimulation/EMG Probe - W/ sterile or reusable?

  The device is supplied as a reusable accessory designed for single-patient use. While it can be used multiple times by the same patient, it should not be shared between patients due to hygiene and safety considerations.

• What regulatory approvals does the Anal 2 Electrode Stimulation/EMG Probe - W/Stop have?

  This device has received FDA 510(k) clearance under K990456 with product code KPI. It is classified as a Class II device and is substantially equivalent to other devices in this category for incontinence treatment.

• How is the Anal 2 Electrode Stimulation/EMG Probe - W/Stop supplied?

  The device is supplied as a reusable accessory for pelvic floor therapy systems. It features two stainless steel electrodes and includes a stop mechanism for safety during insertion and use.